Zeyad Alshethailly
Riyadh
Summary
Regulatory Affairs Manager with over 15 years of experience in pharmaceutical and medical product registration. Demonstrated expertise in SFDA, GCC, and international regulatory frameworks with a proven track record of driving product approvals and maintaining compliance. Adept at leading cross-functional teams, managing complex regulatory submissions, and building strategic relationships with health authorities. Committed to contributing impactful regulatory leadership to enhance organizational success and product lifecycle management.
Overview
17
17
years of professional experience
5
5
years of post-secondary education
Work History
Regulatory Affairs Manager
Vaccine Industrial Company
Riyadh
10.2024 - Current
- Spearheaded submission of eCTD dossiers to the SFDA, ensuring regulatory timeline adherence.
- Partnered with QA and manufacturing departments to align internal processes with regulatory expectations.
- Managed critical regulatory documents such as CPPs and GMP certificates; ensured timely responses to inquiries.
- Strengthened communication with global manufacturing sites to support local market authorization.
Regulatory Affairs Manager
DEEF Pharmaceutical
Riyadh
12.2019 - 10.2024
- Directed the regulatory affairs team to achieve successful approvals for multiple SFDA new drug applications.
- Developed regulatory roadmaps that accelerated time-to-market across GCC regions.
- Established and nurtured agency relationships, optimizing regulatory dialogue and approval processes.
- Oversaw end-to-end submission strategies and life-cycle regulatory compliance for key products.
Regulatory Affairs Manager
Vita Biotics
Riyadh
02.2015 - 02.2019
- Managed regulatory filings for nutritional and pharmaceutical products.
- Designed strategic regulatory frameworks to ensure timely submissions and market entry.
- Led risk analysis and remediation plans to support safe and compliant product launches.
- Liaised with internal and external stakeholders to align product development with regulatory pathways.
Regulatory Affairs Officer
Saudi Food & Drug Authority (SFDA)
Riyadh
01.2009 - 02.2015
- Reviewed and processed regulatory submissions, ensuring full compliance with national guidelines.
- Conducted policy and scientific research to support evidence-based registration decisions.
- Served as primary contact for industry inquiries and documentation follow-ups.
- Provided internal consultation on evolving regulatory standards and practices.
Education
Bachelor of Science - Pharmacy
King Saud University
01.2003 - 01.2008
Skills
Regulatory Strategy & Planning
Regulatory strategy
Regulatory submissions
Global regulatory compliance
Regulatory agency applications
Clinical trial oversight
Product lifecycle management
License renewals
Premarket submissions
Biotechnology industry
Pharmaceutical industry
Regulatory strategy development
Additional Information
Completed specialized training programs in pharmaceutical regulatory affairs., Contributed to the successful registration of over 70 pharmaceutical and medical products.
Personal Information
Nationality: Saudi
Timeline
Regulatory Affairs Manager
Vaccine Industrial Company
10.2024 - Current
Regulatory Affairs Manager
DEEF Pharmaceutical
12.2019 - 10.2024
Regulatory Affairs Manager
Vita Biotics
02.2015 - 02.2019
Regulatory Affairs Officer
Saudi Food & Drug Authority (SFDA)
01.2009 - 02.2015
Bachelor of Science - Pharmacy
King Saud University
01.2003 - 01.2008